DE50100958D1 - STABLE, NASAL, ORAL OR SUBLINGUAL APPLICABLE PHARMACEUTICAL PREPARATION CONTAINING DESMOPRESSIN - Google Patents

STABLE, NASAL, ORAL OR SUBLINGUAL APPLICABLE PHARMACEUTICAL PREPARATION CONTAINING DESMOPRESSIN

Info

Publication number
DE50100958D1
DE50100958D1 DE50100958T DE50100958T DE50100958D1 DE 50100958 D1 DE50100958 D1 DE 50100958D1 DE 50100958 T DE50100958 T DE 50100958T DE 50100958 T DE50100958 T DE 50100958T DE 50100958 D1 DE50100958 D1 DE 50100958D1
Authority
DE
Germany
Prior art keywords
stable
pharmaceutical preparation
sublingual
nasal
oral
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Lifetime
Application number
DE50100958T
Other languages
German (de)
Inventor
Helmut Scheidl
Gerhard Hantich
Ernst Hesse
Thomas Zapf
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Gebro Pharma Fieberbrunn GmbH
Original Assignee
Gebro Pharma Fieberbrunn GmbH
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=3669975&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=DE50100958(D1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Gebro Pharma Fieberbrunn GmbH filed Critical Gebro Pharma Fieberbrunn GmbH
Application granted granted Critical
Publication of DE50100958D1 publication Critical patent/DE50100958D1/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/006—Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
    • A61K38/08—Peptides having 5 to 11 amino acids
    • A61K38/095—Oxytocins; Vasopressins; Related peptides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0043—Nose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P39/00—General protective or antinoxious agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
    • A61P5/10—Drugs for disorders of the endocrine system of the posterior pituitary hormones, e.g. oxytocin, ADH
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/04—Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/12—Antidiuretics, e.g. drugs for diabetes insipidus

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Diabetes (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Hematology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Endocrinology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Physiology (AREA)
  • Otolaryngology (AREA)
  • Nutrition Science (AREA)
  • Obesity (AREA)
  • Urology & Nephrology (AREA)
  • Toxicology (AREA)
  • Emergency Medicine (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

A stable, nasally, orally or sublingually applicable pharmaceutical preparation for administering to patients has an aqueous solution of desmopressin as the active agent. Said solution contains an osmoticum and a buffer which maintains the pH-value in the range of 4 to 6, preferably about 5. The buffer is malic acid, preferably in the form of a racemate. Thereby an improved stability of the desmopressin content in the preparation is obtained.
DE50100958T 2000-02-16 2001-01-10 STABLE, NASAL, ORAL OR SUBLINGUAL APPLICABLE PHARMACEUTICAL PREPARATION CONTAINING DESMOPRESSIN Expired - Lifetime DE50100958D1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
AT0023300A AT409081B (en) 2000-02-16 2000-02-16 STABLE, NASAL, ORAL OR SUBLINGUAL APPLICABLE PHARMACEUTICAL PREPARATION
PCT/AT2001/000007 WO2001060394A1 (en) 2000-02-16 2001-01-10 Stable, nasally, orally or sublingually applicable pharmaceutical preparation

Publications (1)

Publication Number Publication Date
DE50100958D1 true DE50100958D1 (en) 2003-12-18

Family

ID=3669975

Family Applications (1)

Application Number Title Priority Date Filing Date
DE50100958T Expired - Lifetime DE50100958D1 (en) 2000-02-16 2001-01-10 STABLE, NASAL, ORAL OR SUBLINGUAL APPLICABLE PHARMACEUTICAL PREPARATION CONTAINING DESMOPRESSIN

Country Status (20)

Country Link
US (1) US20030119728A1 (en)
EP (1) EP1255557B1 (en)
JP (1) JP2003529562A (en)
AT (2) AT409081B (en)
AU (1) AU771251B2 (en)
CA (1) CA2399822A1 (en)
CZ (1) CZ20022686A3 (en)
DE (1) DE50100958D1 (en)
DK (1) DK1255557T3 (en)
ES (1) ES2210121T3 (en)
HU (1) HU229961B1 (en)
NO (1) NO20023875L (en)
NZ (1) NZ520396A (en)
PL (1) PL357132A1 (en)
PT (1) PT1255557E (en)
SI (1) SI21026B (en)
SK (1) SK285374B6 (en)
TR (1) TR200400234T4 (en)
WO (1) WO2001060394A1 (en)
ZA (1) ZA200205868B (en)

Families Citing this family (20)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB0210397D0 (en) * 2002-05-07 2002-06-12 Ferring Bv Pharmaceutical formulations
AU2003269747A1 (en) * 2002-05-15 2003-12-02 Sun Pharmaceutical Industries Limited A stable aqueous composition of a peptide
AT413078B (en) * 2002-10-10 2005-11-15 Gebro Pharma Gmbh USE OF A BUFFER BASED ON APPLE FOR THE MANUFACTURE OF A NASAL APPLICABLE PREPARATION
US7094545B2 (en) 2003-04-30 2006-08-22 Ferring Bv Pharmaceutical composition as solid dosage form and method for manufacturing thereof
EP1500390B1 (en) 2003-07-25 2005-08-17 Ferring B.V. Pharmaceutical desmopressin composition as solid dosage form and method for manufacturing thereof
ES2260563T3 (en) * 2003-11-13 2006-11-01 Ferring B.V. BLISTER PACKAGE AND SOLID PHARMACEUTICAL FORM FOR IT.
US7018653B2 (en) 2003-12-29 2006-03-28 Ferring B.V. Method for preparing solid dosage form of desmopressin
JP5079257B2 (en) * 2005-05-16 2012-11-21 株式会社三和化学研究所 Preservative for Burkholderiacepacia
SE528446C2 (en) * 2006-03-02 2006-11-14 Ferring Int Ct Sa Pharmaceutical composition comprising desmopressin, silica and starch
ES2319054B1 (en) * 2007-08-06 2010-02-12 Gp Pharm S.A. ORAL PHARMACEUTICAL COMPOSITION OF DESMOPRESINA.
JP5451613B2 (en) 2007-08-06 2014-03-26 アラーガン、インコーポレイテッド Methods and devices for desmopressin drug delivery
US11963995B2 (en) 2008-05-21 2024-04-23 Ferring B.V. Methods comprising desmopressin
LT2712622T (en) 2008-05-21 2016-09-26 Ferring B.V. Orodispersible desmopressin for increasing initial period of sleep undisturbed by nocturia
US20100286045A1 (en) 2008-05-21 2010-11-11 Bjarke Mirner Klein Methods comprising desmopressin
JO3400B1 (en) * 2010-09-30 2019-10-20 Ferring Bv Pharmaceutical composition of carbetocin
JP2011116764A (en) * 2011-02-08 2011-06-16 Fine Seymour H Medical composition containing low dose desmopressin
EP3013318B1 (en) 2013-06-28 2017-04-19 Amgen Inc. Stable liquid formulation of amg 416 (velcalcetide)
JP6341777B2 (en) * 2014-06-30 2018-06-13 リプリーズ バイオファーマシューティクス，エルエルシー Pharmaceutical composition containing low dose desmopressin
WO2016081772A1 (en) * 2014-11-20 2016-05-26 Allergan, Inc. Methods and compositions comprising desmopressin in combination with an alpha-adrenergic receptor antagonist
GB201721846D0 (en) * 2017-12-22 2018-02-07 Arecor Ltd Novel composition

Family Cites Families (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS61126014A (en) * 1984-11-22 1986-06-13 Teijin Ltd Aqueous liquid drug for transnasal administration
JP2505430B2 (en) * 1986-11-04 1996-06-12 帝人株式会社 Powdery composition for nasal administration containing basic amino acid
DE69001991T2 (en) * 1989-11-16 1993-09-23 Phidea Spa LIQUID MEDICINAL APPLICATIONS CONTAINING A POLYPEPTIDE AS AN ACTIVE SUBSTANCE.
CA2070061C (en) * 1991-06-07 2004-02-10 Shigeyuki Takama Physiologically active polypeptide-containing pharmaceutical composition
JPH0640948A (en) * 1992-07-20 1994-02-15 Kyowa Hakko Kogyo Co Ltd Composition for iontophoresis
JP3628713B2 (en) * 1993-06-07 2005-03-16 帝國製薬株式会社 Vaginal preparation containing physiologically active peptide
US5674850A (en) * 1993-12-23 1997-10-07 Ferring Ab High purity desmopressin produced in large single batches
US5482931A (en) * 1993-06-29 1996-01-09 Ferring Ab Stabilized pharmaceutical peptide compositions
CN1305376A (en) * 1998-06-30 2001-07-25 武田药品工业株式会社 Pharmaceutical composition for treatment of diabetes
AU4342100A (en) * 1999-04-16 2000-11-02 Zymetx, Inc. Viral detection method using viral encoded enzymes and chemiluminescent substrates
GB0210397D0 (en) * 2002-05-07 2002-06-12 Ferring Bv Pharmaceutical formulations
AU2003269747A1 (en) * 2002-05-15 2003-12-02 Sun Pharmaceutical Industries Limited A stable aqueous composition of a peptide

Also Published As

Publication number Publication date
HUP0204550A3 (en) 2004-12-28
JP2003529562A (en) 2003-10-07
ZA200205868B (en) 2004-02-10
ES2210121T3 (en) 2004-07-01
SK285374B6 (en) 2006-12-07
AT409081B (en) 2002-05-27
SI21026B (en) 2004-02-29
AU2652001A (en) 2001-08-27
NZ520396A (en) 2004-05-28
AU771251B2 (en) 2004-03-18
NO20023875D0 (en) 2002-08-15
US20030119728A1 (en) 2003-06-26
HUP0204550A2 (en) 2003-05-28
EP1255557B1 (en) 2003-11-12
CA2399822A1 (en) 2001-08-23
HU229961B1 (en) 2015-03-30
NO20023875L (en) 2002-10-11
CZ20022686A3 (en) 2003-01-15
TR200400234T4 (en) 2004-03-22
WO2001060394A1 (en) 2001-08-23
ATE253928T1 (en) 2003-11-15
DK1255557T3 (en) 2004-03-22
SK10492002A3 (en) 2003-02-04
ATA2332000A (en) 2001-10-15
EP1255557A1 (en) 2002-11-13
PT1255557E (en) 2004-04-30
SI21026A (en) 2003-04-30
PL357132A1 (en) 2004-07-12

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Legal Events

Date Code Title Description
8363 Opposition against the patent
8365 Fully valid after opposition proceedings